PURIST Leg Positioning System Operating Instructions Rev 01 Oct 2020

PURIST

OPERATING INSTRUCTIONS Notes for users

Table of Contents Table of Contents... 3 1.

Notes for users ... 5

1.1.

Using this user manual ... 5

1.2.

Instructions are part of the product ... 5

1.3.

Warning and danger symbols ... 6

1.4.

Warning signs and symbols on the device and the packaging ... 6

1.5.

Typographical conventions and symbols ... 8

1.6.

Acronyms and abbreviations ... 8

1.7.

Figures in this user manual ... 8

2.

Product description ... 9

2.1.

Overall illustration ... 9

2.2.

Scope of delivery and components ... 10

2.3.

Check upon receipt ... 12

2.4.

Device properties ... 12

2.5. 2.5.1.

Function / Performance description ... 12 Performance characteristics ... 13

2.6.

Product service life ... 13

2.7.

Warranty and Guarantee ... 13

3.

General Safety Notes ... 14

3.1.

Use for the intended purpose ... 14

3.2.

Use in contradiction to intended use ... 15

3.3.

Hazards when used as intended ... 16

3.4.

Qualifications of operating, assembly and maintenance personnel ... 21

3.5.

Original replacement parts ... 21

3.6.

Notes on product liability ... 21

3.7.

Conformity ... 21

4.

Preparing the Product for Use ... 22

4.1.

Required tools, equipment, and staff ... 22

4.2.

Unpacking the PURIST Leg Positioning System ... 22

4.3. 4.3.1. 4.3.2. 4.3.3. 4.3.4. 4.3.5.

Assembling the PURIST Leg Positioning System ... 24 Mounting the height setting device onto the chassis... 24 Fit the pendulum to the height setting device... 28 Fit the traction rail to the pendulum ... 30 Fit the boot holder to the traction rail ... 34 Fitting the drape holder ... 36

4.4. 4.4.1.

Move PURIST ... 37 Transport position ... 37

4.5.

Final examination ... 40

5.

Operation ... 41

5.1.

Overview ... 41

5.2.

Carrying out the individual steps ... 42

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OPERATING INSTRUCTIONS Notes for users

5.2.1. 5.2.2. 5.2.3. 5.2.4. 5.2.5. 5.2.6. 5.2.7. 5.2.8. 5.2.9. 5.2.10. 5.2.11.

Drive PURIST to the operating table ... 43 Adjusting the height ... 43 Mount the traction boot to the boot holder ... 44 Fixing the castors ... 47 Attach the suction cups to the floor ... 48 Set traction ... 51 Setting the extension ... 55 Setting abduction / adduction ... 60 Setting internal and external rotation of the leg ... 62 Accessory rail ... 64 Removing the traction boot ... 64

5.3.

Prepare PURIST for storage following completion of the operation ... 65

6.

Maintenance / Service ... 66

6.1.

Important information ... 66

6.2.

Checks by the user ... 66

6.3.

Maintenance and service ... 67

6.4.

Maintenance plan ... 67

6.5. 6.5.1. 6.5.2.

Maintenance work ... 68 Cleaning ... 69 Disinfection... 70

7.

Transport, storage, and disposal... 72

7.1.

Decontamination before sending ... 72

7.2.

Transport ... 73

7.3.

Storage ... 74

7.4.

Disposal ... 74

8.

Technical Data ... 75

8.1.

Technical data of the PURIST Leg Positioning System ... 75

8.2.

Setting ranges (nominal values) ... 76

9.

Components and accessory parts ... 77

10.

Accessories ... 78

11.

Revision ... 79

12.

Notes ... 80

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OPERATING INSTRUCTIONS Notes for users

1.

Notes for users

1.1. Using this user manual This user manual should make it possible for you to work safely with the device.  Use this product only in accordance with instructions and warnings in this user manual.

the

safety

 If you have questions regarding the operation of the product and the accessories, please contact the distributor.

1.2. Instructions are part of the product The following documents are a constituent part of the product: • User Manual SUP_7.036 It promotes the intended use of the product and contain important information to install, operate and maintain the device safely and efficiently.  Keep these instructions complete, legible and accessible to personnel at all times.  Read these instructions and especially all safety instructions and warnings with care before you put the device into operation for the first time.  These instructions contribute to reducing the risk of injury or illness to people, and risks of damage, malfunction or inefficient operation of the product.  If you transfer the device to third parties, include these instructions with it.  If you lose these instructions, please order a replacement from your distributor.

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OPERATING INSTRUCTIONS Notes for users

1.3. Warning and danger symbols

DANGER Danger of death or serious bodily injury Failure to observe WILL lead to death or serious bodily injury.

WARNING Danger of death or serious bodily injury Failure to observe CAN lead to death or serious bodily injury.

CAUTION Danger of slight bodily injury A hazard which CAN lead to slight bodily injury.

ATTENTION Warning of damage to components A hazard that CAN cause damage to or malfunctions of the product, equipment, other devices etc.

1.4. Warning signs and symbols on the device and the packaging Symbol

Meaning WARNING

WARNING

Danger symbols which indicate possible personal injuries at the location of the symbol.

CAUTION

Caution: Keep hands clear

Warning sign that indicates danger of hands being crushed at the location of the sign.

Pendulum locked / released

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OPERATING INSTRUCTIONS Notes for users

Instruction/caution sign on the pendulum

CAUTION:

Ensure star knob is fully OPEN before assembly.

Chassis caution label (removable)

Read the user manual

 Read the user manual.  Observe important notice in the user manual.  Read the user manual before installing and using the device.

CE-mark

Batch number Reference Manufacturer Unique Device Identifier Prescription-only Non Sterile Device CAUTION: SEE INSTRUCTION MANUAL READ THE INSTRUCTIONS Medical Device

Body weight

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OPERATING INSTRUCTIONS Notes for users

Symbols on the packaging This side up

Fragile; treat with the required care

Keep dry

1.5. Typographical conventions and symbols Symbol

Meaning Notice with especially useful information and tips



Request for action



Result of a request for action



Listing 1 o

Listing 2

1.6. Acronyms and abbreviations Acronym / Abbreviation

Meaning

PURIST LPS

PURIST Leg Positioning System

Suction cups

The rubber suction cups attached to the locking feet of the booms hold the PURIST in place by means of vacuum.

1.7.

Figures in this user manual Some of the figures in this user manual are schematics where the colors do not necessarily correspond to the final product.

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OPERATING INSTRUCTIONS Product description

2.

Product description

2.1. Overall illustration

1

2

3

4

5

6

7

9

8

10

11

22 19

12

21

13

20

14

19

15

18 17

16

1

Handle

12

Traction rail with traction slider block

2

Abduction / adduction lever

13

Traction hand wheel

3

Release knob for abduction / adduction

14

Pendulum

4

Drape holder

15

Gas strut (gas compression spring)

5

Pendulum mounting bolts

16

Castor

6

Back-rotation lock extension

17

Suction cup

7

Hand wheel extension

18

Boom

8

Traction rail mounting bolts

19

Chassis

9

Foot rotation release

20

Star knob for fixing the height setting device

10

Traction boot

21

Height setting device

11

Boot holder

22

Hand wheel for height adjustment

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OPERATING INSTRUCTIONS Product description

2.2. Scope of delivery and components The PURIST Leg Positioning System (LPS) is delivered in two transport boxes. The following parts of the dismantled product are to be found in these boxes: •

Image

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The common names will be used throughout this manual.

Designation

Description (Common Name)

Reference

PURIST #01

Chassis

681 3117

PURIST #02

Height setting device

681 3118

PURIST #03

Pendulum

681 3119

PURIST #04

Traction rail

681 3114

PURIST #05

Boot holder

681 3120

PURIST #06

Drape holder

681 3116

PURIST / OLH – Boot M

Traction Boot (M)

688 3314

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OPERATING INSTRUCTIONS Product description

CAUTION Danger of injury from lifting transport boxes The transport crate weighs more than 15 kg (33 lb.)  Only physically strong persons may carry this crate alone.

 For more details, please read chapter “Preparing the Product for Use”.

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OPERATING INSTRUCTIONS Product description

2.3. Check upon receipt  Immediately on receipt: check to see that the components are complete and undamaged.  Report any damage during transport to the distributor immediately.

WARNING Risk of contamination This device is not sent in sterile condition. There is a danger of contamination.  Please clean and disinfect the product according to the procedures approved by your organization.

2.4. Device properties The device is intended to hold and position the foot of the leg to be operated on during hip joint replacement. The patient must lie on his / her back. The leg is securely fastened so that it is only movable around the natural hip axis. The product is designed for use on an electrically conducting floor by having electrically conducting castors.

2.5. Function / Performance description The PURIST is a leg positioning system that is used with an operating table. It may only be used in combination with an operating table. PURIST is transportable. It may not however be transported when attached to the patient. PURIST is designed exclusively for indoor use. The product is to be used in combination with the accessories designed for it and in accordance with the documentation supplied with it.

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PURIST

OPERATING INSTRUCTIONS Product description PURIST may be used on patients who have a body weight of up to 227 kg (500 lb). Should, however, the safe working load of the operating table be lower than this, the table load has priority. PURIST may only be used by specialist staff who can position the patient correctly and have made themselves familiar with the product from the user manual. The period of use of PURIST is about 1 to 4 hours per surgical operation.

2.5.1. Performance characteristics •

The patient must lie on his / her back. Holding the leg to be operated on by means of a foot holder during the operation. PURIST is not intended for direct contact with the skin of the patient.

•

Holding the leg be operated on the optimal position for the operating technique of the surgeon.

•

PURIST is transportable. It may not however be transported when attached to the patient.

2.6. Product service life The device was developed for an expected service life of 10 years. After these 10 years of operation, the manufacturer will only be responsible for the safe and correct performance of the device if a complete inspection, normally covered by a warranty agreement, has been carried out and documented.

2.7. Warranty and Guarantee The warranty provisions form a part of the distributor’s General Terms and Conditions. Changes to the device without the manufacturer's permission or use of non-approved spare parts or accessories will void this warranty.

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OPERATING INSTRUCTIONS General Safety Notes

3.

General Safety Notes

3.1. Use for the intended purpose The product is intended solely for use in human hip joint replacement. The product may only be used in combination with an operating table. The patient must lie in the supine position (on the back) during use of the product. The patient can be under a partial or general anesthetic. The product is to be used in combination with the accessories designed for it and in accordance with the documentation supplied with it. The product is designed exclusively for indoor use. The product may only be used by specialist staff who can position the patient correctly and have made themselves familiar with the product from the user manual. The period of use of the product is about 1 to 4 hours per procedure / surgery. The product may be used on patients who have a body weight of up to 227 kg (500 lb.). Should, however, the safe working load of the operating table be lower than this, the table load has priority. Cleaning and disinfection are required. Maintenance shall be performed in accordance with the user manual.

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OPERATING INSTRUCTIONS General Safety Notes

3.2. Use in contradiction to intended use The device including the approved accessories must not be used for any other purpose than that indicated in chapter “Use for the intended purpose”.

WARNING Danger of death or serious bodily injury Electromagnetic fields and rise in potential due to leakage currents of other devices can give rise to potential differences between the device and the patient.  The device may only be used on an electrically conducting floor.

WARNING Danger from use in contradiction to its intended use Use of the device in contradiction to that intended can lead to dangerous situations. The following are included as being in particular contradiction to the intended use:

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•

Use of the product for a purpose other than hip joint replacement in human medicine.

•

Use of the device in environments not set up according to the relevant provisions and guidelines for the erection of medical rooms.

•

Use of a damaged device.

•

Use of an incorrectly assembled device.

•

Allowing unqualified personnel to use the device.

•

Use of accessory rails during an operation. Only for in-house transport and storage.

•

Modification to the device without permission from the manufacturer.

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OPERATING INSTRUCTIONS General Safety Notes

3.3. Hazards when used as intended

CAUTION Danger of injury for osteoporotic patients Leg fractures may occur if excessive mechanical force is applied to the bones of osteoporotic patients, e.g. by traction of the leg.  Do not use the device for osteoporotic patients or use the device with caution.  The operating surgeon is responsible for checking the patient's bone quality and for avoiding excessive load on the bones and joints.

CAUTION Danger of injury due to fingers / hands getting trapped There is a danger that the operator traps his / her hands or fingers between the pendulum and the gas strut.  Adjustments to the extension are to be made with care.  Do not reach between pendulum and gas strut.

CAUTION Danger of injury due to fingers / hands getting trapped There is a danger that the operator traps his / her hands or fingers between the pendulum and the traction slider block when operating the traction.  Adjustments to the traction are to be made with care.  Do not reach between pendulum and traction slider block.

CAUTION Danger of injury due to defective components Defective components pose a risk of injury.  Stop using the device.  Replace defective components only with original replacement parts.  Heed the notes on original replacement parts and product liability if using non-original replacement parts.

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OPERATING INSTRUCTIONS General Safety Notes

WARNING Danger of injury due to thrombosis Holding the leg in one position for a long time during an operation can give rise to blood clots in the veins (thrombosis).  The attending physician must take measures to counter this in operations of longer duration.

CAUTION Risk of injury The pulling force exerted by PURIST during traction can exceed the adhesion of the operating table to the floor. The operation is delayed or cannot be carried out using the device.  Before the operation, ensure that the operating table is adequately fixed to the floor.

CAUTION Risk of injury The traction force exerted by PURIST during traction exceeds the adhesion of the patient to the operating table. The patient, or his / her pelvis is shifted.  Before the operation, ensure that the patient is adequately secured to the operating table.  Use a suitable “perineal operative post” to secure the patient against slipping.  Also use a suitable holder for the other leg to secure the patient against slipping.

CAUTION Risk of injury If the boot is too large, the foot can slip out of it during traction.  Use correct size boot and pad the foot correctly to minimize foot rotation and movement in the boot.

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OPERATING INSTRUCTIONS General Safety Notes

CAUTION Risk of injury The traction force exerted by PURIST during traction can exceed the adhesion of the suction cups to the floor of the operating theater. If the adhesion of the suction cups to the floor gives way suddenly, this can result in abrupt movements of the PURIST and the patient.  Ensure that the suction cups are properly cleaned before starting the operation.  Before starting the operation, ensure that the floor where the equipment is set up has been thoroughly cleaned and has no cracks or gaps.  The operator must be aware of the fact that, in rare occurrences and with inadequate vacuum, the traction force can decrease abruptly. PURIST is therefore explicitly and completely unsuitable for arthroscopic operations at the joint line (off-label).

WARNING Danger of contamination from the product This device is not sent in sterile condition. There is a danger of contamination.  Please clean and disinfect the product according to the procedures approved by your organization.  The product must be covered during the operation.  The operator must remain in the non-sterile area behind the product during the operation.

WARNING Risk of infection from the boot Pathogens can accumulate in the boot.  Avoid direct contact with the patient.  Apply a bandage to avoid direct contact between patient and traction boot during patient preparation and before the traction boot is fitted to the leg to be operated on.  Use disposable socks.  Clean contaminated traction boots by manually washing with mild detergent and warm water.  Check if the boot is in good condition. Replace it if necessary.

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OPERATING INSTRUCTIONS General Safety Notes

WARNING Risk of contamination from the product  Properly disinfect traction boot before and after surgery.  Apply a bandage to avoid direct contact between patient and traction boot during patient preparation and before the traction boot is fitted to the leg to be operated on.

WARNING Danger from electric shock The application part of the device is classified as Type B.  The application of defibrillators and defibrillator monitors is to be conducted as per manufacturer instructions

WARNING Chemical hazard from disinfectants The traction boot may contain residue of disinfectants.  Avoid direct contact with the patient.  Use disposable socks.  Clean contaminated traction boots by manually washing with mild detergent and warm water.  Check if the boot is in good condition. Replace it if necessary

CAUTION Danger from injuries caused by the traction boot (bruises, crushing) Frequent use and cleaning can have a negative effect on the boot material. In operations which last several hours, pressure sores can occur – especially with patients who are slimly built or have sensitive skin.  Check if the boot is in good condition. Replace it if necessary. Make sure of sufficient cushioning and correct fixture of the foot in the boot. Ensure to pad the foot correctly to minimize foot rotation and movement in the boot.

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OPERATING INSTRUCTIONS General Safety Notes

CAUTION Risk of injury Frequent use and cleaning can have a negative effect on the boot material.  Before each use, inspect for visible damage and defects of surfaces, seams and bonds, and control the adhesion of the closures to ensure proper operability of the traction boot.  In case of wear, replace the traction boot in time.

CAUTION Danger of traction boot injuries In operations which last several hours, pressure sores can occur – especially with patients who are slimly built or have sensitive skin.  Select optimal boot size and pad the feet appropriately.

CAUTION Danger of injury due to incorrect interpretation of the scale values for the rotation When the + 20° positions of the boot holder are used, the maximum foot rotation in the direction of the arrow is 20 ° greater than indicated on the scale.  Add 20° to the scale value in the direction of the arrow, subtract 20° in the opposite direction.  The operating surgeon is responsible for determining the bone quality of the patients and for preventing excessive stress on the joints and bones.

CAUTION Risk of injury from PURIST breaking The PURIST may break in case of heavy patients over 227 kg (500 lb.).  Use product only for patients of max. 227kg (500 lb.)

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OPERATING INSTRUCTIONS General Safety Notes

3.4. Qualifications of operating, assembly and maintenance personnel This device may only be assembled, operated and maintained by properly trained technical personnel.  Before assembly, use, and maintenance of the product, carefully read the manual and become familiar with the device.

3.5. Original replacement parts The manufacturer shall only be liable for the safety of the device if the device is maintained by authorized maintenance personnel, and original replacement parts are used. This applies to maintenance, repairs and modifications.

3.6. Notes on product liability Manufacturer’s liability

ADSM shall only be liable for safe operation, reliability and performance of the device if: • • • • •

maintenance is done solely by persons authorized to do this by ADSM assembly is only carried out by competent specialist personnel operation and assembly of the device is carried out in accordance with this manual the product is used within the scope of application described here no unauthorized modifications are made to the product

3.7. Conformity This medical product complies with provisions of the Medical Device REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

Medical Device Class

The PURIST Leg Positioning System and his accessories are classified according to annex VIII, chapter III, rule 1 of the MDR: Class I general, non-sterile, no measuring function.

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